BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENT 201

    MDR report key: 2013557 · Received February 3, 2011

    Report

    Report Number
    9616775-2011-00004
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 6, 2011
    Report Date
    February 3, 2011
    Manufacturer
    VERSAMED MEDICAL SYSTEMS LTD.
    Product Code
    CBK
    PMA / PMN Number
    K0736944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO HAS BEEN REQUESTED BUT HAS NOT YET BEEN PROVIDED.

    Description of Event or Problem · 1

    A SITE REPORTED THAT WHILE TRANSPORTING A PT ACROSS THE ELEVATOR THRESHOLD, THE IVENT 201 SHUT DOWN W/O AN ALARM. THERE WAS NO REPORTED PT INJURY. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVENT 201 CONTINUOUS VENTILATOR CBK VERSAMED MEDICAL SYSTEMS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1